What is it? Why is it important?

The monitor forwards a Follow-Up (FU) letter / e-mail to the Site-INV summarizing:

  • The scope of the performed RMV, including a list of the performed action items
  • Current and ongoing unresolved issues with suggestion for improvement and a timeline for resolution

 

What do I need to do?

If you are the study monitor, write a short FU / e-mail to the Site-INV and include:

  • The status and progress of participant recruitment
  • Monitoring activities performed (e.g. ICs reviewed, SD verification performed)
  • If applicable, study protocol and/or GCP deviations
  • Delivered supplies (e.g. lab kits, IMP/MD)
  • Current and ongoing unresolved issues with relevant improvement and control measures and a timeline for resolution

 

The FU letter / e-mail should:

  • Not contain any surprises or issues that were not previously discussed with the site
  • Describe the status and progress of the study during the monitoring visit

 

The Site-INV files the FU letter / e-mail in the ISF.  The monitor retains a copy of the letter / e-mail

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

References

ICH GCP E6(R2) – see in particular guidelines

  • 4.5 Protocol compliance
  • 5.18 Monitoring activities
  • 6.10 Access to source data / documents

 

ISO 14155 Medical Device – see in particular section (access liable to costs)

  • 9.2.4.7 Monitoring reports
Abbreviations
  • CTU – Clinical Trials Unit
  • FU – Follow-Up Letter
  • GCP – Good Clinical Practice
  • IC – Informed Consent
  • ICH GCP –International Council for Harmonisation Good Clinical Practice
  • ISF – Investigator Site File
  • IMP/MD – Investigational Medicinal Product/Medical Device
  • ISO – International Organisation for Standardisation
  • RMV – Routine Monitoring Visit
  • SD – Source Data
  • Site-INV – Site Investigator
Conduct ↦ Monitoring ↦ Routine Monitoring Visit ↦ Follow-Up Letter
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Quality and Risk
Set-Up Drug or Device
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Current Path (click to copy): Conduct ↦ Monitoring ↦ Routine Monitoring Visit ↦ Follow-Up Letter

Please note: the Easy-GCS tool is currently under construction.